(BFM Bourse) – The European Union has given the green light to the marketing of the Ixchiq vaccine from the French company. This is the third marketing authorization for this vaccine in 2024, after the United States and Canada.
Valneva’s anti-chikungunya vaccine will be able to be marketed in a new geographical area. And not just any new one, since it is the European Union.
The infectious disease vaccine specialist said on Monday that the European Commission had granted marketing authorisation to Ixchiq, its vaccine for the prevention of the disease caused by the chikungunya virus in people aged 18 and over.
Chikungunya virus is a mosquito-borne viral disease that causes headaches, nausea, fatigue, and debilitating joint pain. The disease has been identified in 110 countries, with more than 3.7 million cases reported in the Americas between 2013 and 2023, with significant economic impact.
“Ixchiq is the only approved vaccine against chikungunya in the world, thus providing a response to this unmet medical need,” recalls Valneva.
The group was expecting market authorization for its chikungunya vaccine in Europe in the third quarter of this year. The schedule is therefore respected with today’s announcement.
“In recent years, climate change has led to the spread of the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to previously unaffected areas of Europe. It is essential to provide a vaccine solution not only to European travelers to chikungunya-endemic regions such as South America or Africa, but also to local European populations experiencing attacks from invasive mosquitoes,” said Juan Carlos Jaramillo, Chief Medical Officer of Valneva.
“Following the positive opinion of the CHMP (Committee for Medicinal Products for Human Use) issued on May 30, the European Commission has decided to follow the recommendations of the EMA (European Medicines Agency) and grant marketing authorization to the vaccine against chikungunya in adults,” recalls Invest Securities in its note this Monday.
On the Paris Stock Exchange, the announcement was welcomed. Valneva shares jumped 5.3% to 3.354 euros at around 1:10 p.m.
Two requests in progress
Valneva plans to deliver the first doses of the vaccine in Europe in the fourth quarter of 2024. The group thus receives a third marketing authorization for its Ixchiq vaccine after approval by the American Food and Drug Administration (FDA) in November 2023 and that of Health Canada, the Canadian health authority, at the end of June.
Valneva also said it has submitted a marketing authorisation application to the UK Medicines and Healthcare products Agency (MHRA). The company also points out that a marketing authorisation dossier is also under review by the Brazilian health agency Anvisa, with a potential authorisation in 2024.
In terms of financial spin-offs, Invest Securties points out that Valneva is counting on a target of more than 100 million euros in turnover in year 3 of marketing this vaccine, including the market entry of competing products.
“According to a 2020 market study, the size of the chikungunya vaccine market is estimated at more than $500 million, of which $300-400 million is represented by the travel segment that Valneva is targeting,” the financial intermediary continues.
Valneva has a portfolio of vaccines and vaccine candidates that goes well beyond chikungunya, including a vaccine candidate against Lyme disease, or against the Zika virus, as well as a vaccine already marketed against Japanese encephalitis and another against cholera.
Sabrina Sadgui – ©2024 BFM Bourse
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